Feeding tubes, tissue expanders and peristomal drains are examples of devices that are positioned in the body for medical purposes. These devices may be installed percutaneously, and must be anchored so that they are not pulled out in an unintended manner.
In particular, feeding tubes are used to supply nutrients directly to the stomach. One type of feeding tube is inserted through a stoma in the abdominal wall and extends into the stomach. The stomach communicates with the food source by means of the feeding tube, with food traveling from the food source through the feeding tube and directly into the stomach. Feeding tubes are used for patients who do not have proper motor control to permit ingestion of food through the esophagus, or cannot otherwise ingest food through the mouth and esophagus. Such patients include stroke victims who do have the ability to swallow food.
After the feeding tube is inserted through the abdominal wall and into the stomach, the tube must be secured, or anchored. In the prior art, a feeding tube has a balloon on one end, and an external bolster positioned along the length of the tube. The balloon communicates with a balloon port on the device that allows air or liquids to be placed into the balloon, to expand the balloon. The tube that communicates with the balloon has an opening or port to which a syringe may be fitted for injecting air or liquid material into the balloon. The balloon is expanded by the injected air or liquid material, and as the balloon expands within the stomach, the balloon provides retention means and keeps the tube from pulling out of the stomach. The bolster is positioned against the exterior of the gastric wall and against the patient's skin. The external bolster prevents the tube from being further inserted through the stoma and into the stomach. The bolster and the balloon act together to position and hold the feeding tube, with the outlet of the feeding tube present within the stomach.
The balloon of the prior art device presents problems. The balloon typically lasts from one week to three months. The balloon may break due to compression by the patient's movements, such as the patient simply sitting up. Preexisting small holes in the balloon may release fluids into the stomach. In some patients, the balloon breaks due to hyperacidic stomach content, resulting in an erosion and breakage of the balloon. Once the balloon breaks, the feeding tube may fall out of the stomach in the patient's bed, a condition that may go unnoticed for an extended period.
Once the balloon falls out, a replacement tube needs to be positioned within twelve to twenty-four hours, or the stoma begins to close. If the stoma tract closes, a more significant procedure must be performed, such as an endoscopic procedure to replace the tube with a percutaneous endoscopic gastronomy tube (PEG). Ultimately, a balloon feeding tube replaces the PEG tube and the cycle begins again. In short, balloon feeding tubes rupture unpredictably and prematurely, undesirably leaving the patient's stomach tract free to close.